BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8733340 · Received June 26, 2019

    Report

    Report Number
    3007566237-2019-01385
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    April 2, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KOY A, BOCKHORN N, KUHN AA, ET AL. ADVERSE EVENTS ASSOCIATED WITH DEEP BRAIN STIMULATION IN PATIENTS WITH CHILDHOOD-ONSET DYSTONIA. BRAIN STIMULATION 2019. DOI: 10.1016/J.BRS.2019.04.003. THE LITERATURE ARTICLE NOTED THAT STUDY DATA WAS COLLECTED FROM SITES FROM TWO COUNTRIES: AUSTRIA (AT) AND GERMANY (DE); HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH COUNTRY OCCURRED IN. ATHIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES AND PUBLICATION DATE WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DATA ON PEDIATRIC DBS IS STILL LIMITED BECAUSE OF SMALL NUMBERSIN SINGLE CENTER SERIES AND LACK OF SYSTEMATIC MULTI-CENTER TRIALS. THE AUTHORS EVALUATE SHORT- AND LONG-TERM ADVERSE EVENTS (AES) OF PATIENTS UNDERGOING DEEP BRAIN STIMULATION (DBS) DURING CHILDHOOD AND ADOLESCENCE. DATA COLLECTED BY THE GERMAN REGISTRY ON PEDIATRIC DBS (GEPESTIM) WERE ANALYZED ACCORDING TO REVERSIBLE AND IRREVERSIBLE AES AND TIME OF OCCURRENCE WITH RELATION TO DBS-SURGERY: INTRAOPERATIVE, PERIOPERATIVE (< 4 WEEKS), POSTOPERATIVE (4 WEEKS < 6 MONTHS) AND LONG TERM AES (>6 MONTHS). 72 PATIENTS WITH CHILDHOOD-ONSET DYSTONIA FROM 10 DBS-CENTERS, WHO RECEIVED 173 DBS ELECTRODES AND 141 IMPLANTABLE PULSE GENERATORS (IPG), WERE INCLUDED IN THE REGISTRY. MEAN TIME OF POSTOPERATIVE FOLLOW-UP WAS 4.6 ± 4 YEARS. IN TOTAL, 184 AES WERE DOCUMENTED IN 53 PATIENTS (73.6%). 52 DBS RELATED AES IN 26 PATIENTS (36.1%) REQUIRED 45 SUBSEQUENT SURGICAL INTERVENTIONS 4.7 ± 4.1 YEARS (RANGE: 3 MONTHS -15 YEARS) AFTER INITIAL IMPLANTATION. THE TOTAL RISK OF AN AE REQUIRING SURGICAL INTERVENTION WAS 7.9% PER ELECTRODE-YEAR. HARDWARE-RELATED AES WERE THE MOST COMMON REASON FOR SURGERY. THERE WAS A TENDENCY OF A HIGHER RATE OF AES IN PATIENTS AGED 7-9 YEARS BEYOND 6 MONTHS AFTER IMPLANTATION. THE INTRAOPERATIVE RISK OF AES IN PEDIATRIC PATIENTS WITH DYSTONIA UNDERGOING DBS IS VERY LOW, WHEREAS THE RATE OF POSTOPERATIVE HARDWARE-RELATED AES IS A PROMINENT FEATURE WITH A HIGHER OCCURRENCE COMPARED TO ADULTS, ESPECIALLY ON LONG-TERM FOLLOW-UP. FACTORS LEADING TO SUCH AES MUST BE IDENTIFIED AND PATIENT MANAGEMENT HAS TO BE FOCUSED ON RISK MINIMIZATION STRATEGIES IN ORDER TO IMPROVE DBS THERAPY AND MAXIMIZE OUTCOME IN PEDIATRIC PATIENTS. REPORTED EVENTS: 1. ONE PATIENT EXPERIENCED TECHNICAL DEFECT OF THE LEAD IN THE LONG-TERM INTERVAL WHICH DID NOT REQUIRE INTERVENTION. ALL PATIENTS WERE IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) FOR EITHER ISOLATED INHERITED AND IDIOPATHIC DYSTONIA, COMBINED INHERITED AND IDIOPATHIC DYSTONIA, OR ACQUIRED DYSTONIA. THE FOLLOWING DEVICE INFORMATION WAS IDENTIFIED IN THE LITERATURE ARTICLE: INS MODELS 37612, 37601, 37602/37603, 7428, 7426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527430 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN1

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR